CompletedNot Applicable

TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study

United States4 participantsStarted 2016-10

Plain-language summary

The goal of this research project is to establish that in short-term use, tolvaptan is a safe and potentially effective new therapy for cystinuria, by conducting a short-term pilot study of the safety and tolerability of this drug, and assess impact on urinary stone risk parameters, among adolescent and young adult patients with clinical cystinuria.

Who can participate

Age range12 Years – 29 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and females age 12 - 29 years * Weight ≥ 25kg (55 lbs) * Confirmed cystinuria diagnosis * Specific blood test levels (done within the past 6 months) Exclusion Criteria: * Concurrent non-renal disease that might increase risk of complications due to aquaresis * Liver or biliary disease (chronic or acute) * Malabsorption syndrome or other gastrointestinal condition that may interfere with response to therapy * Non-cutaneous malignancy within last 5 years * History of adverse reaction or allergy to Tolvaptan or other arginine vasopressin V2-receptor antagonists

What they're measuring

Urinary Cystine Supersaturation (mg/L) at High Dose (Day7-8)

Timeframe: 23 days

Trial details

NCT IDNCT02538016

SponsorCaleb Nelson

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

Results submitted2020-05-01

View on ClinicalTrials.gov More Cystinuria trials